羧甲基淀粉钠工艺对片剂崩解性能的影响  

Effect of Sodium Carboxymethyl Starch Process on Disintegration Performance of Tablets

作　　者：周晔 王天瑶 琚冬冬 刘秀燕 单艺璇 ZHOU Ye;WANG Tianyao;JU Dongdong;LIU Xiuyan;SHAN Yixuan(Jiangsu Hengrui Pharmaceutical Co.,Ltd.,Lianyungang 222047,China)

机构地区：[1]江苏恒瑞医药股份有限公司,江苏连云港222047

出　　处：《化工管理》2024年第2期156-159,共4页Chemical Engineering Management

摘　　要：文章着重分析羧甲基淀粉钠在用于改善难溶性药物的片剂在高湿条件下崩解不佳时的效果。以难溶性药物来曲唑作为本次研究的模型药物,采用常规的口服片剂生产工艺制备药物片剂。结果显示使用无交联工艺的羧甲基淀粉钠的片剂,在高湿条件(92.5%RH)出现崩解不佳或不崩解现象,使用经交联工艺的羧甲基淀粉钠的片剂在高湿条件(92.5%RH)下崩解良好。经交联化的羧甲基淀粉钠空间结构更强,在高湿条件下的凝胶化反应较弱,吸湿溶胀后仍有一定的空间间隙供水分进入片芯,故而合理控制反应过程中氢氧化钠浓度和交联剂用量可使难溶性药物在高湿条件下保持良好的崩解性能。The article focuses on analyzing the effect of carboxymethyl starch sodium on the poor disintegration of tablets used to improve insoluble drugs under high humidity conditions.The insoluble drug letrozole was used as the model drug for this study,and the drug tablets were prepared using conventional oral tablet production processes.The results showed that tablets using non crosslinked carboxymethyl starch sodium exhibited poor or no disintegration under high humidity conditions(92.5%RH),while tablets using crosslinked carboxymethyl starch sodium exhibited good disintegration under high humidity conditions(92.5%RH).The cross-linked carboxymethyl starch sodium has a stronger spatial structure,and the gel reaction is weak under high humidity conditions.After moisture absorption and swelling,there is still a certain amount of water in the space gap entering the core.Therefore,reasonable control of the concentration of sodium hydroxide and the amount of cross-linking agent in the reaction process can maintain good disintegration performance of insoluble drugs under high humidity conditions.

关 键 词：羧甲基淀粉钠 难溶性药物 崩解 

分 类 号：TQ460.7[化学工程—制药化工]